Percent of persons with controlled blood pressure, defined as less than 140/90 at 2 consecutive visits.

Original Secondary Outcome Measures ICMJE

Same as current

Current Other Outcome Measures ICMJE (submitted: February 10, 2014)

testing time [ Time Frame: 24 months ]

Time in minutes to order and interpret tests. Reported by Primary Care Providers and pharmacists.

Testing Cost [ Time Frame: 24 months ]

Reported by Primary Care Providers and pharmacists. Cost in dollars of testing and pharmacist time.

Original Other Outcome Measures ICMJE

Same as current

Descriptive Information

Brief Title ICMJE

Screen-and-treat Program for Chronic Kidney Disease- High Risk Persons

Official Title ICMJE

Can a Targeted Screen-and-treat Program for Chronic Kidney Disease Improve Blood Pressure (BP) Management Among Persons at High Risk for Complications ?

Brief Summary

The overall hypothesis of this trial is that screening for chronic kidney disease, followed by education or treatment program will improve blood pressure control among hypertensive non-diabetic persons.

Hypothesis 1a. The CKD CDSS will result in improved BP levels and BP control, compared to usual care.

Hypothesis 1b. Within the CKD CDSS group, utilization of ACE/ARB among persons with albuminuria will increase during follow-up.

Aim 2. To evaluate the acceptability and feasibility of implementing a CDSS for improving disease awareness and staging by primary care providers, compared with usual care, among persons with eGFRcreat < 60 ml/min/1.73m^2.

The CKD CDSS plus pharmacist (CDSS PLUS) extends beyond CDSS alone. PCPs randomized to this arm will have the additional option to refer their higher-risk patients to a clinical pharmacist-led CKD management program with education. A primary care clinical pharmacist will schedule a series of appointments with patients found to have confirmed higher-risk CKD (defined as eGFRcreat-cys <45, or eGFR 45-59 and ACR ≥ 30 mg/g). The pharmacist will follow treatment algorithms recommended by the 2012 KDIGO international CKD guidelines, and designed by a team of internists and nephrologists.

Study Arms

No Intervention: Usual Care

The patients in this arm will receive normal care.

Active Comparator: Screen-Educate

Education program to improve blood pressure control among hypertensive non-diabetic persons. The Screen and Educate CDSS arm will recommend using creatinine, cystatin C and albuminuria for risk stratification, followed by guideline-concordant CKD management appropriate for CKD stage.

Intervention: Other: Screen-Educate

Active Comparator: Screen-Educate and Intensify Treatment

Education and treatment program to improve blood pressure control among hypertensive non-diabetic persons. The Screen-Educate and Intensify Treatment is the CDSS plus a pharmacist-led CKD management program (CDSS PLUS) will attempt to improve BP management and patient-centered outcomes among persons with newly stratified higher risk CKD based on creatinine, cystatin c and albuminuria.

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Active, not recruiting

Estimated Enrollment ICMJE

135

Estimated Completion Date

December 2017

Primary Completion Date

January 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

The entire primary care medical practice at SFVAMC will be considered. Randomization will occur at the team (nurse) level. Within each team, individual patients will be considered eligible for chronic kidney disease screening by this protocol and inclusion in our trial if they have hypertension without concomitant diabetes, and no prior recorded diagnosis of chronic kidney disease. Hypertension will be defined as systolic blood pressure >140 or diastolic blood pressure >90 mmHg at more than two encounters (any encounter) within the previous 3 years or a documented diagnosis of hypertension (listed in problem list or ICD-9 code). Diagnosed chronic kidney disease will be defined as a documentation of chronic kidney disease in the problem list or ICD-9 code or on-going nephrology follow up. We define diagnosed chronic kidney disease without consideration of estimated glomerular filtration rate by creatinine or albumin-creatinine-ratio in the laboratory section of the medical record, since work from our group and others has shown that awareness and recognition of chronic kidney disease is extremely low, even among persons with documented reduced estimated glomerular filtration rate or albuminuria. Persons will be required to have seen their physician at least one time within the past 18 months.

Exclusion Criteria:

Kidney transplant recipients, pregnant women, and individuals with an estimated glomerular filtration rate <15 ml/min/1.73 m2 will be excluded from this study as they likely need specialty care for uncontrolled hypertension. Persons aged >80 will be excluded because data on aggressive blood pressure lowering in this population are less clear and adverse effects associated with aggressive blood pressure control have been well documented. We will exclude persons with New York Heart Association class III or IV heart failure, known ejection fraction <25%, or documented allergy to Angiotensin-Converting Enzyme/Angiotensin II Receptor Blockers. Other exclusion criteria relate to the required ability to communicate with providers and provide informed consent: prevalent dementia, impaired cognition or severe mental illness; expected life expectancy <6 months; severe visual impairment in the absence of an available caretaker who can read.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 80 Years (Adult, Senior)

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects